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SSPVA40NB9

Millipore

Optiscale® 40 Viresolve® Prefilter

Prefiltration before parvovirus removal

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Synonym(s):
OptiScale-40 Viresolve Prefilter
eCl@ss:
32031690

material

cellulose fiber prefilter (inorganic filter aid)
mixed cellulose esters (MCE)
polypropylene
polypropylene support

Quality Level

reg. compliance

meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)

manufacturer/tradename

OptiScale®

parameter

0.03 bar max. differential pressure (0.5 psid) (Reverse)
100 mL process volume
2.1 bar max. differential pressure (30 psid) (Forward)

technique(s)

protein purification: suitable

filtration area

5 cm2

impurities

≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
<0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

matrix

Viresolve® Prefilter

fitting

female Luer-Lok® inlet connection
male Luer outlet slip

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MSPV05FS1MSPV10FS1SZRV025NB9
technique(s)

protein purification: suitable

technique(s)

protein purification: suitable

technique(s)

protein purification: suitable

technique(s)

protein purification: suitable

filtration area

5 cm2

filtration area

0.55 m2

filtration area

1.1 m2

filtration area

3.5 cm2

matrix

Viresolve® Prefilter

matrix

-

matrix

-

matrix

Viresolve® NFR

fitting

female Luer-Lok® inlet connection, male Luer outlet slip

fitting

1.5 in. TC inlet connection (Disposable), 1.5 in. TC outlet connection (Disposable)

fitting

1.5 in. TC inlet connection (Disposable), 1.5 in. TC outlet connection (Disposable)

fitting

female Luer-Lok® inlet connection, male Luer outlet slip

reg. compliance

meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)

reg. compliance

-

reg. compliance

-

reg. compliance

-

General description

Device Configuration: Capsule

Application

Prefiltration before parvovirus removal

Other Notes

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

Preparation Note

Sterilization Method
3 autoclave cycles of 60 min @ 123 °C
This product was manufactured with a Viresolve® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

Legal Information

Luer-Lok is a registered trademark of Becton-Dickinson & Co.
OptiScale is a registered trademark of Merck KGaA, Darmstadt, Germany
VIRESOLVE is a registered trademark of Merck KGaA, Darmstadt, Germany

Storage Class Code

11 - Combustible Solids

WGK

WGK 3


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